STEAM TAPE ST-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10732224730193), received between Aug 5, 2019 and Aug 5, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Non Reproducible Results” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2019Problem with Sterilization; Non Reproducible Results

  THE TAPE FOR STERILE PROCESSING DID NOT TURN COLORS AFTER STERILIZING THE TRAYS AS INTENDED, TO CONFIRM STERILITY. TRAYS WERE RE-OPENED AND REPROCESSED AS A PRECAUTION. ALL MACHINE PARAMETERS HAD BEEN MET. INTEGRATORS INSIDE THE TRAYS HAD PASSED. SOME LOADS WERE PROCESSED WITH BIOLOGICAL INDICATORS, WHICH HAD ALSO PASSED. WE PULLED THE LOT NUMBER OF THE TAPE THAT WE BELIEVED TO BE AFFECTED AND RAN A TEST. TAPE FROM 2 DIFFERENT ROLLS OF THE SAME LOT NUMBER HAD DIFFERENT RESULTS. 1 WAS FINE, 1 WAS NOT. WE THOUGHT THAT IT WAS JUST 1 BAD ROLL. THIS MORNING THERE WERE SEVERAL MORE TRAYS THAT THE TAPE DID NOT LOOK AS DARK, SO WE PULLED AND REPROCESSED THOSE AS WELL. WE RAN ANOTHER TEST AND WE WERE NOT ABLE TO RECREATE THE ISSUE. WE HAVE NOW PULLED ALL ROLLS WITH THAT LOT NUMBER. THIS ERROR IS A GOOD CATCH. IT DID NOT REACH THE PATIENT OR CAUSE ANY HARM.

  Patient problems: No Patient Involvement

  MAUDE report 8860229 ↗